Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns
BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving diagnostic inaccuracy with potential for adverse diagnostic outcomes. No illnesses or injuries have been reported; the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Chloramphenicol-30 ug, a diagnostic product used for in vitro antibiotic susceptibility testing. The recall encompasses approximately 2.3 million units across multiple lot numbers, distributed nationwide and internationally.
The discs may have reproducibility, accuracy, and quality control failures during antibiotic susceptibility testing for H. influenzae. These failures could cause product discard, delayed test results, or inaccurate diagnostic outcomes.
Potential adverse effects include diagnostic delays, selection of inappropriate antibiotics, or extended duration of antibiotic exposure during the treatment process. Clinical laboratories and healthcare facilities using affected product lots should be aware of this Class II recall.
The recalled product
- Product
- BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,363,168
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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